Monday May 1, 2017 0 comments
ENGLEWOOD -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) announced it has begun a single injection study to meet the unmet medical need of treating the severe pain and loss of function associated with Kellgren-Lawrence (KL) grade 4 osteoarthritis of the knee (OAK).
"In compliance with FDA guidance, this trial will be smaller than our prior trials with 171 patients, randomization of 6 to 1 (Ampion™/Saline) on patients with severe OAK, defined radiologically as KL 4 patients,” said Dr. David Bar-Or, Ampio chief science officer.
“The 6-1 randomization will preserve blinding and prevent the bias in the assessment that might be associated with an unblinded evaluation, however, only Ampion treated patients will be evaluated.
“This 12-week study will evaluate the responder rate of Ampion treated patients as defined by OARSI, which includes pain, function, and patient global assessment (PGA). The outcome of this study will contribute to the label of Ampion which may include pain, function, and patient global assessment.
“Using the OMERACT-OARSI responder rate definition and the analysis proposed in this protocol, all previous Ampion single injections clinical trials would have successfully met this endpoint."
"Ampion meets an unmet medical need for a very large and growing patient population -- KL 4 OAK patients,” said Chris Ehrlich, managing director and head of the West Coast office of Locust Walk who was recently appointed to assist Ampio with partnering Ampion.
“With trial initiation underway, Locust Walk looks forward to launching our efforts to fuel the growth of this promising company by connecting them with the right partners."
"Ampio plans to advance necessary Biologic License Application (BLA) activities in parallel with this clinical trial to expedite the path to potential FDA approval.” said Michael Macaluso, Ampio CEO.
“We are unaware of any other FDA approved treatments for the less severe form of OAK (KL 2 & KL 3), which have received this broad of labeling. KL 4 patients are suffering from continuous pain, severely restricted activity, and are going to their physicians more frequently seeking relief than KL 2 or KL 3 patients.
“We are hopeful Ampion may prove helpful to these KL 4 patients as it has an excellent safety profile, with no significant side effects, and offers an alternative to knee replacement surgery.
Ampio said it believes that Ampion, a low molecular weight fraction of human serum albumin with anti-inflammatory properties, will be identified as a "reference product" upon FDA approval of their BLA.
Reference products are granted 12 years of exclusivity under the PHS Act, 42 U.S.C. § 262(k)(7). Specifically, FDA is not permitted to approve an application for a biosimilar or interchangeable product until 12 years after the date of the first licensure of the reference product.
The existing Ampion portfolio has patent coverage in all major jurisdictions throughout the world (U.S., Europe, Australia, Brazil, Canada, China, Eurasia, Hong Kong, India, Indonesia, Israel, Japan, Korea, Mexico, Malaysia, New Zealand, Philippines, Singapore, South Africa) for pharmaceutical compositions and methods of treating a range of conditions.
The portfolio includes 125 issued patents and 85 pending applications throughout seven primary patent families having expiration dates that extend to 2035.